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FDA 510(k)

Athena III Cervical Plate System

K-Number: K230301 · 2023-03-07

ApplicantMedyssey USA, Inc.
Decision Date2023-03-07
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Athena III Cervical Plate System is a medical device manufactured by Medyssey USA, Inc.. It received FDA 510(k) clearance on 2023-03-07 under approval number K230301. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Athena III Cervical Plate System?

Athena III Cervical Plate System is a medical device that received FDA 510(k) clearance on 2023-03-07. It is manufactured by Medyssey USA, Inc.. The 510(k) number is K230301.

When was Athena III Cervical Plate System approved by the FDA?

Athena III Cervical Plate System received FDA 510(k) clearance on 2023-03-07, under approval number K230301.

What company makes Athena III Cervical Plate System?

Athena III Cervical Plate System is manufactured by Medyssey USA, Inc..

What is the FDA product code for Athena III Cervical Plate System?

The FDA product code for Athena III Cervical Plate System is KWQ.

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Related Devices (Code: KWQ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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